Prostate Cancer Screening Trial Using Imaging

Conditions

Prostate Neoplasm

Brief summary

Participants will be recruited from the community and attend a screening clinic and undergo the following screening tests: 1. Bi-parametric MRI - reported by a radiologist and CAD-AI system 2. Multiparametric ultrasound - including shearwave elastography 3. A standard-of-care PSA test A systematic +/- targeted biopsy will be performed if any tests are positive, independent of the other tests.

Thorley N, Parry T, Brembilla G, Giganti F, Barrett T, Eldred-Evans D, Mayor N, Lamb A, Hubbard Cristinacce PL, Gong F, Tam HH, Sokhi HK, Padhani AR, Moore CM, Atkinson D, Ahmed HU, Punwani S.

2026-02-19

10.1007/s00330-025-12250-4

Perceived patient burden and acceptability of MRI in comparison to PSA and ultrasound: results from the IP1-PROSTAGRAM study

David Eldred‐Evans, Mathias Winkler, Natalia Klimowska‐Nassar, Paula Burak, Martin J. Connor et al. (13 authors)

Prostate Cancer and Prostatic Diseases2023-03-311 citations

10.1038/s41391-023-00662-6

ReIMAGINE Prostate Cancer Screening Study: protocol for a single-centre feasibility study inviting men for prostate cancer screening using MRI

Teresa Marsden, Derek J. Lomas, Neil McCartan, Joanna Hadley, Steve Tuck et al. (20 authors)

BMJ Open2021-09-0118 citations

10.1136/bmjopen-2020-048144

Population-based prostate cancer screening using a prospective, blinded, paired screen-positive comparison of PSA and fast MRI: The IP1-PROSTAGRAM study.

David Eldred‐Evans, Paula Burak, Martin J. Connor, Emily Day, Martin Evans et al. (17 authors)

Journal of Clinical Oncology2020-05-204 citations

10.1200/jco.2020.38.15_suppl.5513

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

MALE

Age

50 Years to 69 Years

Healthy volunteers

Yes

Inclusion criteria

1. Men aged between 50 and 69 years inclusive at the time of study entry 2. Participants must be fit to undergo all procedures listed in the protocol 3. Estimated life expectancy of 10 years or more 4. An understanding of the English language sufficient to understand written and verbal information about the trial and consent process 5. Participants must be willing and able to provide written informed consent

Exclusion criteria

1. Previous PSA test or prostate MRI within the prior two years of screening/consent visit 2. Evidence of a urinary tract infection or history of acute prostatitis within the last 6 months 3. Previous history of prostate cancer, prostate biopsy or treatment for prostate cancer 4. Any potential contraindication to MRI 5. Any potential contraindication to prostate biopsy 6. Dementia or altered mental status that would prohibit the understanding or rendering of informed consent. 7. Any other medical condition precluding procedures described in the protocol

Design outcomes

Primary

Measure	Time frame	Description
The Proportion of Men With a Positive MRI Defined by a Score of 3 or Greater	Through study completion, an average of 1 month	Men with a positive MRI defined by a score of 3 or greater

Secondary

Measure	Time frame	Description
The Proportion of Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater	Through study completion, an average of 1 month	Men With Screen-positive Prostate MRI Defined by a Score of 4 or Greater
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 3 or Greater	Through study completion, an average of 1 month	Men With Screen-positive Prostate US Defined by a Score of 3 or Greater
The Proportion of Men With Screen-positive Prostate US Defined by a Score of 4 or Greater	Through study completion, an average of 1 month	Men With Screen-positive Prostate US Defined by a Score of 4 or Greater
The Proportion of Men With Screen-positive PSA Defined by a >/=3ng/ml	Through study completion, an average of 1 month	Men with screen-positive PSA defined by a \>/=3ng/ml

Countries

United Kingdom

Participant flow

Pre-assignment details

Participant enrollment (411) exceeded the planned protocol enrollment (406) due to the logistics of mpMRI at the screening site. The TMG agreed that over-recruitment could occur on a single day to maximize MRI availability

Participants by arm

Arm	Count
MRI, PSA and US Group Men screened by PSA, MRI and US	408
Total	408

Baseline characteristics

Characteristic	MRI, PSA and US Group
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	56 Participants
Age, Categorical Between 18 and 65 years	352 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants
Race (NIH/OMB) Asian	94 Participants
Race (NIH/OMB) Black or African American	132 Participants
Race (NIH/OMB) More than one race	9 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants
Race (NIH/OMB) Unknown or Not Reported	18 Participants
Race (NIH/OMB) White	155 Participants
Sex: Female, Male Female	0 Participants
Sex: Female, Male Male	408 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 408
other Total, other adverse events	0 / 408
serious Total, serious adverse events	0 / 408